Working Group on Future Clinical Research Directions on Omega-3 Fatty Acids and Cardiovascular Disease

Bethesda Marriott Hotel, Pooks Hill

June 2, 2004

Full Report of the Working Group

Summary of Meeting

A Working Group meeting was held on June 2, 2004 chaired by Dr. Scott Grundy. The main objective of this working group was to review evidence-based reports on the effects of omega-3 fatty acids on CVD and CVD risk factors, recently released by the Agency of Healthcare Quality and Research, and to advise the NHLBI and Office of Dietary Supplements on future directions for research to fill gaps in knowledge on these issues.

The working group concluded that the body of evidence supports the hypothesis that ingestion of omega-3 fatty acids reduces CVD risk but that a definitive trial is needed. The evidence comes from cohort studies conducted in a variety of population samples, including U.S. samples, that consisted mostly of individuals without CVD. There have been few clinical trials conducted, which were generally in men who had experienced a heart attack, and mostly conducted in Europe and elsewhere, where background diets and medical care differ from the U.S. Much of the trial evidence is based on one large trial that had an open-label control group rather than a placebo control group. The benefit does not appear to function through effects on CVD risk factors, but seems to work through an independent mechanism, probably on arrhythmias and sudden cardiac death. The body of evidence is highly suggestive but not definitive that omega-3 fatty acids reduce CVD.

The working group recommended that a randomized clinical trial be conducted to test the effects of omega-3 fatty acids on CVD events. They recommended the trial be conducted in a high-risk population comprised of both high-risk primary prevention as well as secondary prevention participants using a design testing two dietary supplements (fish-based EPA and DHA as well as plant-based alpha- linolenic acid, the latter because of its high public health applicability) and a placebo control group. They recommended that ancillary studies should be encouraged to evaluate mechanisms by which omega-3 fatty acids may reduce CVD and to examine dose-response relationships. A report of the working group meeting is currently under preparation.

Participants List


Scott Grundy, M.D., Ph.D. (Chair)
Professor
The University of Texas Southwestern Medical Center at Dallas
Center for Human Nutrition
Dallas, TX

Christine M. Albert, M.D., M.P.H.
Assistant Professor of Medicine
Division of Preventive Medicine
Harvard Medical School
Brigham and Women's Hospital
Boston, Massachusetts

Lawrence J. Appel, M.D., M.P.H.
Professor of Medicine, Epidemiology, and International Health (Human Nutrition)
Johns Hopkins Medical Institutions
Baltimore, Maryland

Ethan Balk, M.D.
Tufts-New England Medical Center
Boston, Massachusetts

Michael A. Blazing, M.D.
Assistant Professor of Medicine
Cardiology Associates
Duke University Medical Center
Durham, North Carolina

Marianne Geleijnse, Ph.D.
Wageningen University
Division of Human Nutrition
THE NETHERLANDS

Abhinav Goyal, M.D.
Cardiology Fellow
Department for Medicine and Cardiology
Duke University Medical Center
Durham, North Carolina

Eliseo Guallar, M.D.
Assistant Professor and Core Faculty Member
Welch Center for Prevention, Epidemiology, and Clinical Research
Johns Hopkins Medical Institutions
Baltimore, Maryland

William S. Harris, Ph.D.
Co-Director, Lipid and Diabetes Research Center
Mid America Heart Institute of St. Luke's Hospital System
Kansas City, Missouri

Terry A. Jacobson, M.D.
Associate Professor of Medicine
Director, Office of Health Promotion and Disease Prevention
Emory University School of Medicine
Atlanta, Georgia

Penny M. Kris-Etherton, Ph.D.
Distinguished Professor of Nutrition
Department of Nutritional Sciences
The Pennsylvania State University
University Park, Pennsylvania

Frank M. Sacks, M.D.
Professor
Department of Nutrition
Harvard School of Public Health
Boston, Massachusetts

David Siscovick, M.D., M.P.H.
Professor of Medicine and Epidemiology
Co-Director, Cardiovascular Health Research Unit
University of Washington
Seattle, Washington

NIH Staff
National Heart, Lung, and Blood Institute

Jeffrey A. Cutler, M.D.
Senior Scientific Advisor
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland

Paula T. Einhorn, M.D.
Medical Officer
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland

Nancy L. Geller, Ph.D.
Director, Office of Biostatistics Research
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland

David A. Lathrop, Ph.D.
Leader, Ischemia, Arrhythmia, and Sudden Cardiac Death Scientific Research Group
Division of Heart and Vascular Disease
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland

Catherine (Cay) M. Loria, Ph.D., M.S., M.A.
Epidemiologist
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland

Eva Obarzanek, Ph.D., M.P.H., R.D.
Acting Leader, Prevention Scientific Research Group
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland

Charlotte A. Pratt, Ph.D.
Research Nutritionist
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland

Yves Rosenberg, M.D.
Medical Officer
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland

Denise G. Simons-Morton, M.D., Ph.D.
Director, Clinical Applications and Prevention Program
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, Maryland

Office of Dietary Supplements

Paul M. Coates, Ph.D.
Director, Office of Dietary Supplements
National Institutes of Health
Bethesda, Maryland

Anne Thurn, Ph.D.
Director, Evidence-Based Review Program
Office of Dietary Supplements
National Institutes of Health
Bethesda, Maryland
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